Prevention Challenges

Why Problems with Reprocessing Ureteroscopes ‘Haven’t Gone Away’

“This indicates that the problems haven’t gone away, and possibly, more people are filing reports since they heard about this risk and they were urged by the FDA to submit reports,” Cori Ofstead said of the more than 100 medical device reports filed on flexible ureteroscopes since the agency announced an investigation into reprocessed urological endoscopes.

More than 100 new medical device reports (MDRs) on flexible ureteroscopes have been filed with the U.S. Food and Drug Administration since the agency released a letter to healthcare providers last spring announcing its investigation into numerous MDRs involving reprocessed urological endoscopes.

This was among the key findings presented in a recent OR Manager webinar featuring Cori Ofstead, an epidemiologist with more than 25 years of research experience.

Since the FDA issued its letter on April 1, 2021, 105 MDRs have been filed with the agency on flexible ureteroscopes. This includes more than 35 in both August and October of 2021. These reports included:

  • Patient injuries or exposures (5)
  • Reprocessing breaches (11)
  • Contamination (18)
  • Damaged scopes (72)

“This indicates that the problems haven’t gone away, and possibly, more people are filing reports since they heard about this risk and they were urged by the FDA to submit reports,” Ofstead said.

In addition to filing MDRs for adverse events involving urology scopes, the FDA also urged manufacturers to:

  • Carefully follow reprocessing instructions
  • Increase awareness of reprocessing instructions for reusable accessories
  • Cease use of damaged scopes
  • Develop schedules for inspection and maintenance
  • Inform patients of risks associated with reprocessed urology endoscopes

Ofstead offered a detailed breakdown of the complex designs of ureteroscopes, which are significantly smaller than many other endoscopes and therefore require inspection under magnification after each cleaning. She also suggested quality management programs worth implementing. These included considering the role of single-use ureteroscopes.

Ofstead leads a multidisciplinary team that specializes in designing and conducting real-world studies to validate healthcare guidelines, treatments, and product claims.

Click here to watch the full webinar.

More Urology Articles
‘Practical, Inexpensive, and Harmless’ Ways to Reduce Pain During Cystoscopy
Best Practices
A systematic review uncovers ways to reduce the pain of flexible cystoscopy without the use of drugs.
4 Reasons Urologists, Procurement Managers Would Switch to Single-Use Cystoscopes
Emerging Technologies
The authors of a May study investigated worldwide market readiness of single-use flexible cystoscopes through a survey of urologists and procurement managers in France, Germany, Italy, Spain, the United Kingdom, Japan, and the United States.
More From Single-Use Endoscopy

Emerging Technologies

Physicians, researchers, and other industry professionals will gather in San Diego for Digestive Disease Week 2022 after the COVID-19 pandemic forced the event to go virtual each of the past two years.

5 Things Urologists Were Talking About at AUA 2022

Endoscopy Tech

Patient engagement and advancing diversity in urologic oncology were among the topics probed over three days in New Orleans as the American Urology Association held its annual meeting.

A Matter of Time: Shifting the Healthcare Paradigm With Single-Use

Emerging Technologies

At DeviceTalks Boston, med-tech executives talk of a day when single-use endoscopy is the standard of care and reusable endoscopes are “hanging in a museum.”